Sonidegib

Author: Anoma Ranaweera B.V.Sc; PhD (Clinical Biochemistry, University of Liverpool, UK); Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, August 2016.

Introduction

In July 2015 the US FDA (Food and Drug Administration) approved sonidegib (Odomzo®; Novartis, New Jersey, USA) for the treatment of adult patients with locally advanced basal cell carcinoma (BCC).

The European Commission approved the use of sonidegib for basal cell carcinoma in August 2015. In June 2016, sonidegib was granted marketing authorisation in Switzerland for treatment of adults with advanced basal cell carcinoma. The drug is also approved in Australia. Additional regulatory submissions are being reviewed by health authorities worldwide.

What is sonidegib used for?

Sonidegib is indicated for the treatment of adult patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. 

How does sonidegib work?

Dosage and administration of sonidegib

Link to key clinical-trial evidence about sonidegib

Potential drug interactions with sonidegib

What are the adverse effects of sonidegib?

The most common (≥ 10%) adverse reactions associated with sonidegib treatment in clinical trials were:

Warnings and precautions

Use of sonidegib in pregnancy

Use of sonidegib in nursing mothers

Paediatric use of sonidegib

The safety and effectiveness of sonidegib has not been established in children (<18 years of age).

Geriatric use of sonidegib

Hepatic impairment and sonidegib

Renal impairment and sonidegib

Effect of sonidegib on age, sex, weight and race

New Zealand approved datasheets are the official source of information for these prescription medicines, including approved uses and risk information. Check the individual New Zealand datasheet on the Medsafe website.

Related information

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